Senior Process Engineer Cell Therapy Comparability

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Summary:

We are looking for a Senior Process Engineer to join the Comparability Team within the Cell Therapy Global Manufacturing Science and Technology (GMSAT) department. The successful candidate will collaborate with the GMSAT teams in Seattle and New Jersey locations in the US and support efforts related to tech transfer and lifecycle management. The Senior Process Engineer will be responsible for leading cross-departmental teams, and planning/executing risk assessments and strategy development for viral vector analytical comparability exercises to enable change implementation. This role is responsible for developing study design and statistically derived criteria to evaluate pre-change and post-change results and summarize the strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to insure project advancement, rapid and best in class execution, and communication of challenges/opportunities. The Senior Process Engineer will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of viral vector products.

The roles and responsibilities include, but are not limited to, the following:


Collaborate with process engineers and analytical scientists and guide comparability design by applying in-depth viral vector manufacturing process knowledge

Perform statistical analysis of product attribute data as well as statistical tests and evaluation to assist the design and execution of comparability exercises for cell therapy products

Lead execution of process risk assessments, development of criteria justifications, and development of comparability protocols

Author and review regulatory filings summarizing the strategy and results from comparability exercises

Develop, understand, and manage tools and templates that can be used to quantify potential impact of changes on process performance and product quality

Contribute to alignment and harmonization of comparability strategies across multiple sites

Leverage and maintain strong relationships across multiple sites

Up to 10% travel may be required (primarily domestic travel)


Basic Qualifications


B.S. or M.S. in Chemical Engineering, Biochemical Engineering or equivalent with 7-10 years relevant experience in biologic or viral vector process/analytical development or commercial manufacturing process technical support

Demonstrated ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects working in a self-driven, performance/results oriented, fast paced matrix environment

Demonstrated ability to perform/document complex manufacturing processes and provide technical support in a clinical/commercial GMP environment

Experience in development and/or characterization of biologics and/or viral vectors manufacturing processes

3 or more years of experience working in a GMP environment, ICH guidelines, control strategy development, and working within a Quality organization

Excellent problem-solving skills

Proficiency utilizing MS Office products and statistical software (R, JMP, Minitab)

Able to creatively manage time and escalate relevant issues to project lead and line management

Strong scientific and technical writing

Detail oriented with excellent verbal and written communication skills


Preferred Qualifications:


Preference given to candidates with experience writing regulatory submissions

Knowledge of virology a plus


SUPERVISOR

Principal Process Engineer, Cell Therapy Comparability

DEPARTMENT

Cell Therapy Global Global Manufacturing Science and Technology

PREREQUISITES

Experience with tech transfer, manufacturing technical support, process development, GMP experience

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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